Quality Assurance Associate, II - Senior (In Plant Operations)

About AGC Biologics 
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.   

 

The Quality Assurance Associate II-Senior (In Plant Operations) is responsible for providing (24/7/365) Quality support to the activities listed below at the Boulder, CO site.

ESSENTIAL DUTIES AND RESPONSIBILITIES

1. Oversee Manufacturing floor operations and provide quality oversight.
2. Specific Job Responsibilities include but not limited to:

• Review of executed manufacturing batch records for completeness, compliance, and accuracy to support product lot disposition.
• Review and approve logbook activities.

• Approve equipment and room change-over operations.

• Approve and execute area change-over operations.
• Support review and approval of Master Production Records (MPRs).
• Conduct review and approval of GMP documents (i.e. Standard Operating Procedures (SOPs), Forms, Work Instructions, etc.) in the electronic Document Management System.
• Support Deviations, CAPAs and Change Control, when required.
• Collaborate in the resolution of issues associated with the manufacturing operations, with the QA point-of-contact, to provide guidance and facilitate the resumption of manufacturing activities post deviation detection.
• This position is a Night Shift and will require to work 12 hour shifts to support Manufacturing, Quality Control, and Engineering Operations activities.

 

 KNOWLEDGE, SKILLS, AND ABILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• Technical and analytical understanding of Biologics Manufacturing and testing.
• Knowledge of regulatory compliance principles, strategy and rational as they relate to Biologics Manufacturing.
• Good oral and written communication skills.
• Good organizational skills.
• Demonstrated experience in areas of teamwork and problem-solving.
• Ability to work on moderately complex problems where analysis of situations or data requires an evaluation of factors.
• Understanding of basic scientific/technical concepts

EDUCATION and/or EXPERIENCE

• Bachelor’s degree in Biology, Chemistry or other relevant science/engineering discipline or equivalent work experience.
• Previous experience in QA or related document control experience, as required below:
  
  • Associate II – Minimum 2 years
  • Associate III – Minimum 5 years
  • Senior --  Minimum 8 + years
• Equivalent education and experience may substitute for stated requirements

 

COMPENSATION RANGE:

$59,760 - $115,390

 

Fluctuations in the job market may necessitate adjustments to pay ranges. Final pay determinations will depend on various factors, including, but not limited to experience levels, knowledge, skills, and abilities.

Benefits available to Team Members include subsidized insurance for the Team Member and designated dependents (medical, vision, dental, life and disability), eligibility to participate in the AGC Biologics 401(k) plan (including a generous matching contribution from the company and immediate vesting), vacation, sick time, and parental leave.

Team Members are also eligible to receive a discretionary annual bonus commensurate to the level of the role. The payout is based on both the company’s performance and the Team Member’s performance.

 

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC